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Updating the Biologically Based Dose-Response Model for the Nasal Carcinogenicity of Inhaled Formaldehyde in the F344 Rat

Authors: Rory B. Conolly, Jeffry Schroeter, Julia S. Kimbell, Harvey Clewell, Melvin E. Andersen, P. Robinan Gentry

The authors describe an updated biologically based dose-response (BBDR) model that addresses uncertainties through refined dosimetry modeling, revised analysis of labeling index data, and an extended dataset where both inhaled (exogenous) and endogenous formaldehyde form DNA adducts. These updates represent an iterative refinement of the 2003 model, incorporating new data and insights to reduce identified model uncertainties. This model, scaled up to humans, has informed dose-response conclusions reached by several international regulatory agencies.